Korea lowers risk rating for autoimmune cell therapy in biotech deregulation push

The health ministry said it will reclassify autoimmune cell therapy as low-risk, cutting years from the path to treatment as part of a package aimed at bringing South Korea's biotech rules in line with the United States, the European Union and Japan.

The Ministry of Health and Welfare announced the regulatory rationalization measures jointly with other government departments, saying the country's safety-first approval regime and closed medical-data environment have held back the bio industry and delayed patients' access to treatment.

Under the change, therapy using a patient's own blood-derived immune cells, cultured outside the body, moves from the current "medium-risk" category to "low-risk." Hospitals have had to complete a preliminary clinical study taking two to three years before treating patients directly; after the change, they can submit literature and go straight to a treatment-plan review by the advanced regenerative bio committee. The government cited Japan's classification of proven autoimmune cell therapy as low-risk in making the case for the shift.

The measures also open up stored raw materials. Cell-processing facilities currently must collect umbilical cord blood and embryonic stem cells themselves, which has limited supply even when other institutions hold vetted stock. The government will amend the Advanced Regenerative Medicine and Advanced Biologics Act to let facilities obtain cord blood from cord-blood banks and other holders for research and treatment of rare and hard-to-treat diseases, pointing to Taiwan's practice of distributing cells from verified banks.

For stem cells, the government will fund a clinical study of its own: 330 patients over two years, targeting knee osteoarthritis and chronic pain, to establish safety and efficacy before moving to treatment.

The review system itself will be split. Rather than one committee handling every case regardless of risk, the government will run separate committees by risk level, introduce a fast-track review for identical or repeated treatment plans, and add specialist staff to offer tailored consultations. Researchers and hospitals have spent long stretches preparing review documents from the earliest design stage, delaying studies.

On medical data, the government will revise the enforcement rules of the Bioethics and Safety Act so that research using pseudonymized health information — data altered so individuals cannot be identified — falls outside the act's definition of human-subject research, exempting it from institutional review board scrutiny and, the ministry expects, shortening the time needed to develop medical AI.

It will also push an amendment to the act introducing broad consent, allowing data already collected to be used in secondary research provided subjects' rights are protected, including the right to refuse. National standards for pseudonymizing structured medical data will be set and extended to all health data, and rules for cloud-based remote analysis environments will be issued so researchers need not visit hospitals in person.

"This regulatory rationalization lowers the threshold for advanced regenerative treatment by a step, guaranteeing patients a swift opportunity for treatment, and redesigns our regulatory level to match competing countries so that Korea's world-class medical data can be used as a core growth engine for the advanced bio industry," Health Minister Jung Eun-kyung said.

The ministry presented the package as part of a deregulation task for the autonomous-vehicle and bio growth engines under the presidential Regulatory Reform Committee, which held its second plenary meeting the same day.